Surgical procedures involve the use of many instruments and supplies. Despite existing protocols that are supposed to account for medical items before, during, and after each surgical procedure, surgical teams still lose track of medical items used during the procedure and leave medical items in the patient after the procedure is complete. Foreign objects that remain in the body after surgery may cause considerable post-operative pain, injure other anatomic structures, and/or cause infection or other foreign body reactions. Studies and government data indicate that a surgical instrument is inadvertently left in a patient between 4,500 and 6,000 times a year in the United States alone. Medical items are left behind in about 1 out of every 5,500 procedures, according to a 2014 study published by the Journal of the American College of Surgeons. Sponges, difficult to detect once saturated with blood, account for more than two-thirds of such incidents.
Due to the risks of such complications and associated financial/malpractice liabilities, most medical facilities must employ extensive positive control protocols to account for all medical items in the surgical environment before the patient is closed. These processes must account for all items that are used by the surgical team, including all surgical instruments, scalpels, knives, other hardware, containers, and absorbent items, such as sponges and towels. The location of each article that enters the surgical field must be positively controlled before, during, and after the medical procedure. In a typical surgical procedure, 20 to 300 medical items are used. In some surgical procedures, however, up to 600 medical items may be used, thus complicating the task of accounting for each medical items and increasing the risk of misplacing a medical item.
When the surgeon closes up the patient, the surgical team must positively identify the location of each item used during the surgical procedure. If a particular medical item cannot be accounted for, a search for the item is required, resulting in costly delays. Additional equipment, such as x-ray machines, may be required to x-ray the patient to determine if the medical item remains in the patient. Even when x-ray equipment is used, medical items can be missed in the x-ray photograph. If the medical item indeed remains in the patient, the patient must be reopened to retrieve the medical item. During this search, the patient must remain under anesthesia, extending beyond the planned duration for the medical procedure. The occasion for search and the need for x-ray equipment translate to extra costs to patients and insurance companies. Furthermore, such incidents require the submission of time-consuming incident reports by members of the surgical team and costly administrative review.